Method and apparatus for facilitating access through a patient tissue

ABSTRACT

A system for facilitating access through a substantially planar and laterally oriented patient skin surface includes a guiding substrate extending substantially parallel to the skin surface and selectively directly fastened thereto. The guiding substrate supports a guiding structure in a substantially fixed relationship to an access site of the skin surface. A tool carriage is configured to accept surgical tools for sequential interaction with the access site. The tool carriage engages the guiding structure such that the tool carriage is guided along a predetermined action path when motive force is provided to the tool carriage. The tool carriage is guided along the action path with an incising tool in penetrating contact with the access site of the skin surface to create a laterally elongate incision at the access site. The tool carriage is guided along the action path to substantially close the incision at the access site.

RELATED APPLICATION

This application claims priority from U.S. Provisional Application No.61/654,175, filed 1 Jun. 2012, the subject matter of which isincorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to an apparatus and method forfacilitating access through a patient tissue and, more particularly, toa method and apparatus for facilitating access through a patient skinsurface.

BACKGROUND OF THE INVENTION

Many surgical procedures are performed through an incision in apatient's skin surface. The skin surface is cut, generally through theuse of a hand-held scalpel blade, to produce a surgical wound/incisionat a desired access site. The surgical incision is usually substantiallylinear, but because the cut is made free-hand, the incision may not beprecisely located or shaped (e.g., there may be curved or curvilinearaspects to the incision), and may have differing cut depths along itslength according to the varying pressure applied to the scalpel blade.The surgeon may also inadvertently make small angulations during thisfreehand incising, which “bevels” the incision edges and therebycontribute to healing delays and/or poor scar formation.

The surgical procedure is carried out in any desired manner, using thesurgical incision for access. Once the invasive portion of the surgicalprocedure is complete, the surgeon begins approximating the surgicalincision by pulling the incision edges together into alignment andplacing sutures, clips, staples, adhesives, or other fasteners to holdthe edges closed for healing. However, this portion of the accessprocedure is also generally accomplished manually and freehand, so theapproximation and fastener placement are often uneven and/or impreciselydone, despite the best efforts of the surgeon. Also, despite an emphasison incision edge eversion during surgeon training, advantageous contactbetween the deep dermis on both edges of the incision does not alwaysoccur during freehand incision approximation, thus potentially hinderinghealing of the surgical incision.

SUMMARY OF THE INVENTION

In an embodiment of the present invention, a system for facilitatingaccess through a patient skin surface. The skin surface is substantiallyplanar and laterally oriented. A guiding substrate extends substantiallyparallel to the skin surface and is selectively directly fastenedthereto. The guiding substrate, when fastened to the skin surface,supports a guiding structure in a substantially fixed relationship to anaccess site of the skin surface. A tool carriage is configured to acceptat least a chosen one of a plurality of surgical tools for sequentialinteraction with the access site. The tool carriage includes a followingstructure configured for selective engagement with the guiding structuresuch that the tool carriage is guided along a predetermined action pathwhen the following structure and guiding structure are engaged andmotive force is provided to the tool carriage. When the surgical tool isan incising tool, the tool carriage is guided along the action path withthe incising tool in penetrating contact with the access site of theskin surface to create a laterally elongate incision at the access site,using the incising tool, and thereby provide access below the skinsurface. When the surgical tool is a closure tool, the tool carriage isguided along the action path to substantially close the incision at theaccess site, using the closure tool, and thereby prevent access throughthe incision below the skin surface.

In an embodiment of the present invention, a method of facilitatingaccess through a patient skin surface is provided. The skin surface issubstantially planar and laterally oriented. A guiding substrate isdirectly fastened to the skin surface. The guiding substrate extendssubstantially parallel to the skin surface. A guiding structure issupported in a substantially fixed relationship to an access site of theskin surface with the guiding substrate. A tool carriage is configuredto accept at least a chosen one of a plurality of surgical tools forsequential interaction with the access site. The tool carriage includesa following structure. The following structure is selectively engagedwith the guiding structure. The tool carriage is guided along apredetermined action path when the following structure and guidingstructure are engaged and motive force is provided to the tool carriage.When the surgical tool is an incising tool, the tool carriage is guidedalong the action path with the incising tool in penetrating contact withthe access site of the skin surface to create a laterally elongateincision at the access site, using the incising tool, and therebyprovide access below the skin surface. When the surgical tool is aclosure tool, the tool carriage is guided along the action path tosubstantially close the incision at the access site, using the closuretool, and thereby prevent access through the incision below the skinsurface.

In an embodiment of the present invention, a device for facilitatingaccess through a patient skin surface is provided. The skin surface issubstantially planar and laterally oriented. A pair of guiding rails arefastened to the skin surface. The guiding rails are laterally spacedalong the skin surface with an access site on the skin surfaceinterposed laterally between the guiding rails. At least one toolcarriage is configured to movably engage the guiding rails such thatmotive force exerted in the transverse direction upon the tool carriagecauses the tool carriage to move, guided by the rails, in the transversedirection. An incision tool is selectively carried by a tool carriageand accordingly is guided by the movable engagement between the toolcarriage and the guiding rails to create a transversely extendingincision in the skin surface at the access site and thereby provideaccess through the skin surface. A closure tool is selectively carriedby a tool carriage and accordingly guided by the movable engagementbetween the tool carriage and the guiding rails to close the incision inthe skin surface at the access site and thereby substantially preventaccess through the skin surface.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, reference may be made tothe accompanying drawings, in which:

FIG. 1 is a top view of a plurality of components according to anembodiment of the present invention;

FIGS. 2A-2B are top views of a component of the embodiment of FIG. 1 intwo example configurations;

FIG. 3A is a perspective side view of a component of the embodiment ofFIG. 1;

FIG. 3B is a bottom view of the component of FIG. 3A;

FIG. 4 is a perspective side view of the components of FIGS. 2A and3A-3B in an example use configuration;

FIG. 5A is a top view of a component of the embodiment of FIG. 1;

FIG. 5B is a side view of the component of FIG. 5A;

FIG. 6A is a top view of a component of the embodiment of FIG. 1;

FIG. 6B is a side view of the component of FIG. 6A;

FIG. 7 is a top view of a component of the embodiment of FIG. 1;

FIG. 8 is a schematic top view of a component of the embodiment of FIG.1;

FIG. 9 is a top view of the component of FIGS. 5A-5B in an example useconfiguration;

FIG. 10 is a top view of the component of FIGS. 6A-6B in an example useconfiguration; and

FIG. 11 is a schematic side view of a component of the embodiment ofFIG. 1.

DESCRIPTION OF EMBODIMENTS

In accordance with the present invention, FIG. 1 depicts a plurality ofcomponents comprising an apparatus 100 for facilitating access through apatient tissue. The patient tissue will be discussed herein assubstantially planar and laterally oriented—i.e., approximatelycoinciding with the plane of the page in FIG. 1. The patient tissue isshown and described herein at least as skin surface, but the patienttissue (and corresponding surgical procedure) could be any desired typessuch as, but not limited to, surface skin tissue, subsurface skintissue, muscle tissue, nerve tissue, organ tissue, connective tissue,bone tissue, or any other suitable human, animal, or other patienttissue use environment for the present invention.

FIGS. 2A-2B depict different example configurations of a first componentof the apparatus 100. A guiding substrate 202 (two shown) extendssubstantially parallel to a skin surface 204 and is selectively directlyfastened thereto. For example, the guiding substrate 202 can have anadhesive backing (not shown) that sticks to a suitably prepared skinsurface 204, may be sutured or otherwise anchored to the skin surfaceusing a separate fastener (not shown), or may be fastened to the skinsurface in any desired manner. The guiding substrate 202 shown in FIGS.2A-2B is a substantially planar sheet of material and is adhered to theskin surface 204. In FIG. 2A, the guiding substrate 202 is substantiallyrigid. In FIG. 2B, each guiding substrate 202 includes a substantiallyflexible portion 206 and a substantially rigid portion 208. Thearrangement of FIG. 2B may be helpful, for example, when the user wishesto stretch, deform, or otherwise manipulate the patient's skin surface204 during the surgical procedure, since the substantially flexibleportion 206 facilitates the ability of the guiding substrates 202 toremain pliable but still firmly and directly fastened to the skinsurface 204 to support the other portions of the apparatus 100 for use.Optionally, some or all of the guiding substrates 202 could be removedand possibly replaced to facilitate various steps of the surgicalprocedure described below. For example, the substantially rigid portions208 could be removed from the substantially flexible portions 206 tofacilitate flexibility of the guiding substrates 202 during accessthrough the skin and then replaced to return some degree of rigidity tothe guiding substrates.

At least one guiding structure 210 is supported by a correspondingguiding substrate 202 in a substantially fixed relationship to an accesssite 212 of the skin surface 204. In FIGS. 2A-2B and similarly arrangedFigures, the access site 212 is located substantially laterally betweenthe two guiding substrates 202 in an interposed relationship. In theembodiment shown in the Figures, the guiding structures 210 are a pairof guiding rails 210 which are fastened to the skin surface 204 in alaterally spaced relationship. Here, the guiding rails 210 are arrangedsubstantially parallel to one another (and to the skin surface 204),extending along the skin surface adjacent the access site 212 locatedtherebetween, for interaction as described below with other componentsof the apparatus 100. In other words, one guiding rail 210 is locatedlaterally to a first side (e.g., the left) of the access site 212 andthe other guiding rail 210 is located laterally to a second side (e.g.,the right) of the access site. Optionally, the guiding rails 210 may belocated laterally equidistant from the access site 212 when the guidingsubstrates 202 are fastened to the skin surface 204. However, one ormore guiding structures 210, having any desired configuration andspacing relative to each other and to the access site 212, can beprovided by one of ordinary skill in the art for a particularapplication of the present invention. The guiding substrate(s) 202and/or guiding structures 210 may be removed from the above-describeduse position at/near the access site 212 during at least a portion ofthe surgical procedure, optionally being replaced as described abovetoward the end of the surgical procedure once access through the skinsurface 204 is no longer needed.

FIGS. 3A-3B depict top and bottom views, respectively, of a placementjig 314 according to an embodiment of the present invention. Theplacement jig 314 shown includes two jig channels 316 spaced apredetermined distance apart by a jig body 318. The placement jig 314 isselectively attachable (directly or indirectly) to the guidingsubstrates 202 for maintaining a substantially fixed relationshipbetween the guiding substrates at a first spacing distance 320. Here, asshown in FIG. 4, the guiding rails 210 each mate with a jig channel 316.The term “mating” is used herein to indicate a relationship in which thecontours of two structures are at least partially matched or coordinatedin at least two dimensions. For example, both the guiding rails 210 andthe jig channel 316 could have profiles that are—in any dimensionthereof—protruding, retracted, concavely curved, convexly curved,planar/linear, or any combination of those or other profile shapes.

Optionally, the dimensions of the guiding rails 210 and jig channels 316may be chosen such that the guiding rails are frictionally engaged withthe jig channels. For example, when these structures are in the FIG. 4arrangement, a user may be able to pick up and manipulate the placementjig 314 to place the guiding rails 210 (and attached guiding substrates202) into a desired position without touching the guiding structures orrails 202 or 210 directly. Other means for engaging the placement jig314 with a particular guiding substrate 202 (directly or via the guidingstructure or another member) include magnetism, suction, staticelectricity, mechanical means (e.g., lifting peg/hole), or any othersuitable engagement scheme.

Particularly when the guiding substrates 202 are attached to the skinsurface 204 using adhesive on the underside of the guiding substrates,the placement jig 314 can be used to help position the guidingsubstrates 202 in a relatively precise and desirable manner, as comparedto freehand placement. For example, the placement jig 314 and guidingrails 210 could be arranged as shown in FIG. 4 to place the guidingrails at a predetermined lateral neutral rail space distance (here,first spacing distance 320) relative to one another before the guidingrails are fastened to the skin surface 204, and the placement jigmaintains that neutral rail space distance between the guiding railsduring fastening of the guiding rails to the skin surface.

When the guiding substrates 202 are adhesively fastened to the skinsurface 204, the placement jig 314 can hold the guiding rails 210 asshown in FIG. 4, the placement jig can be manipulated to bring the(adhesive) underside of the guiding substrates 202 into contact with theskin surface, and then the placement jig can be removed, leaving theguiding substrates and associated guiding rails fastened to the skinsurface in the arrangement (spacing and relative orientation) shown inFIG. 1A. One of ordinary skill in the art can readily provide aplacement jig 314 having any suitable configuration, able to contactand/or grasp any type of guiding structure, in any desired manner, for aparticular application of the present invention. When used, theplacement jig 314 can help to place one or more guiding substrates 202and/or guiding structures into a desired position on the skin surface204 at a predetermined absolute or relative location, and in arepeatable manner. Accordingly, use of the guiding structures as a“landmark” during the surgical procedure may be enhanced for certain useenvironments of the present invention, though the substantially fixedspacing relationship between the guiding structure and the access sitewill generally be present even without the use of the placement jig 314.

Turning to FIGS. 5A-5B, the guiding rails 210 have already been fastenedto the skin surface 204 at the first spacing distance 320. The accesssite 212 is interposed laterally between the guiding substrates 202. Theapparatus 100 includes at least one tool carriage 522 having a followingstructure 524 which is configured for selective engagement with theguiding structure such that the tool carriage is guided along apredetermined action path 526 when the following structure and guidingstructure are engaged and motive force is provided to the tool carriage.As shown in FIG. 5A, the depicted tool carriage 522 has a pair offollowing structures 524 which include following channels 528 configuredfor sliding engagement with the guiding rails 210 (omitted from FIG. 5Bfor clarity). Optionally, guiding rails 210 or other guiding structurescould also or instead be provided (not shown) on a tool carriage 522 forengagement and interaction with a guiding substrate 202 in a mannersimilar to that described herein with reference to the guidingstructure(s) provided on the guiding substrate.

Regardless of the way in which the guiding structure(s) and toolcarriage(s) 522 are provided and configured, motive force exerted on thetool carriage 522 in the transverse direction 530 will cause the toolcarriage to move, guided by engagement between the following channels528 and the guiding rails 210, in the transverse direction. The actionpath 526 may be substantially linear, particularly when the guidingrails 210 are substantially linear, and may be transversely orientedacross the skin surface 204 or may have any other desired configuration.For example, a longitudinally (i.e., perpendicular to the lateral skinsurface) slanting action path 526 may be provided when the guiding rails210 are thicker at one end than at the other—such a longitudinallyslanting action path may be useful in providing a varying-depthincision. It is contemplated that, for many embodiments of the presentinvention, the three-dimensional spatial configuration of the actionpath 526 will bear a direct correspondence to at least a portion of thethree-dimensional spatial configuration of the guiding structure.

The tool carriage 522 is configured to accept at least a chosen one of aplurality of surgical tools 532 for sequential interaction with theaccess site 212. For example, and as shown in FIGS. 5A-5B, the toolcarriage 522 accepts a scalpel 534. As another incising option (notshown), the tool carriage 522 could accept just a blade of a scalpel534, without the handle, a Bovie knife, a cutting laser, a cuttingelectrode, or any other incising tool. The tool(s) 532 may be stocksurgical tools or may be at least partially custom-made and/orcustom-configured for a particular use. The tool carriage 522 shownincludes a tool grasper 536 which is configured to hold the scalpel 534.The tool grasper 536 may have any desired configuration for holding anydesired tool 532, using any desired type of engagement (including, butnot limited to, frictional, compression, adhesive, magnetic, or anyother suitable engagement type or combination thereof) and may bereadily provided by one of ordinary skill in the art for a particularapplication of the present invention.

A lateral width of the tool carriage 522 may be chosen to exert a forceupon the skin surface 204 as desired by the user when the tool carriageand guiding structure 210 are engaged together and the guiding substrate202 is fastened to the skin surface 204. For example, when the apparatus100 includes attachment of two guiding rails 210 to the skin surface 204at the first spacing distance 320 relative to one another, the lateralwidth of the tool carriage 522 may be chosen to pull the guiding rails210 closer together than the first spacing distance (i.e., the toolcarriage will exert compressive force on the skin surface throughengagement between the guiding structure and the following structure524). Similarly, the lateral width of the tool carriage 522 may bechosen to push the guiding rails 210 further apart than the firstspacing distance (i.e., the tool carriage will exert tensile force onthe skin surface through engagement between the guiding structure andthe following structure 524), to a second spacing distance 538. Thelatter situation will be more common when the apparatus 100 is beingused to guide an incising tool (e.g., a scalpel) along the action path526 to create an incision in the skin surface 204.

That is, when a surgeon is creating a freehand incision in a patient'sskin surface 204, the surgeon will manually spread/tension the skinsurface with her thumb and fingers so that she is cutting a relativelytaut surface. However, such manually applied tension is inherentlyvariable and unrepeatable, both along and perpendicular to the actionpath 526. Using the apparatus 100, a predetermined and repeatabletension can be applied uniformly to the access site 212 (e.g., byplacement of the guiding rails 210 at the second spacing distance 538)to assist the incising tool 532 (carried by the tool carriage 522) increating a relatively uniform and controlled incision.

Suitable tension for application during travel of the incising toolcarriage 522 along the action path 526 might be, for example, in therange of two hundred to fifteen hundred grams, and preferably fivehundred grams, for certain applications of the present invention. One ofordinary skill in the art can readily configure/design an apparatus 100having appropriate dimensions—e.g., lateral width of the tool carriage522—to achieve a desired amount of laterally oriented tension on theskin surface 204 during use. The tool carriage 522 could also or insteadhave a variable width provided by, for example, a spring (not shown)bearing some physical relationship to the desired tension, such that thewidth of the tool carriage can vary under influence of the spring duringtravel along the action path 526 to maintain constant tensile force uponthe guiding structure(s) and, by virtue of the above-describedattachments, upon the skin surface 204. Another example of avariable-tension tool carriage 522 includes a structure (not shown)allowing the user to manually set and/or maintain a width of the toolcarriage during use of the apparatus 100.

Regardless of whether tensioning or compressive force(s) are exerted bythe process, during use of the tool carriage 522 of FIGS. 5A-5B with anincising tool 532 the tool carriage may be automatically and/or manuallyguided along the action path 526 by any desired motive force, including,but not limited to, a user's manual manipulation, a small motor, amechanical linkage, or any other suitable force. When the tool carriage522 carries an incising tool 532, a cutting or blade portion of theincising tool—such as the scalpel 534 shown in the Figures—is broughtinto penetrating contact with the access site 212 of the skin surface204 to create a laterally elongate incision at the access site, andthereby provide access below the skin surface.

When used, a scalpel 534 (or any other suitable tool 532) can bepositioned as desired with respect to the skin surface 204. For example,a #10 scalpel blade could be placed at a twenty- to thirty-degree anglewith respect to the skin surface, while a #15 scalpel blade could beplaced at a forty-five degree angle with respect to the skin surface.Similarly, the scalpel 534 could be positioned to penetrate any desireddistance into the skin surface 204 at the access site 212, such as inthe range of two to twenty millimeters deep. The depth of penetration isbased upon skin thickness and a desired penetration depth may varyresponsive to patient characteristics (e.g., body fat). The toolcarriage 522 and/or tool grasper 536 may be selectively adjustable,before and/or during use, to change the relative relationship betweenthe held/carried tool 532 and the skin surface 204 at the access site212 as desired.

FIGS. 6A-6B depict a tool carriage 522′ which is configured to acceptanother type of surgical tool 532 than the tool carriage 522 of FIGS.5A-5B. The tool 532 shown in combination with the tool carriage 522′ ofFIGS. 6A-6B is a closure tool, here a surgical stapler 640. While thetool carriage 522′ could be the same tool carriage 522 as previouslydescribed, the tool grasper 536 shown in FIGS. 6A-6B differs from thatof FIGS. 5A-5B, so the tool carriage 522′ described with reference toFIGS. 6A-6B will be presumed to be a different one than that referencedin the above description of FIGS. 5A-5B.

As shown in FIGS. 6A-6B, the stapler 640 is carried by the tool carriage522′ similarly to the way that the previously described tool carriage522 holds the scalpel 534. When motive power of any suitable type isprovided to the apparatus 100, the tool carriage 522′ is guided alongthe action path 526, which may coincide with the incision and/or theaction path traveled by the previously described tool carriage 522. Thestapler 640 is then actuated to substantially close the incision at theaccess site 212, thereby preventing access through the incision to thearea below the skin surface 204.

As shown in FIGS. 6A-6B, the stapler 640 is configured to place aplurality of laterally spaced penetrating fasteners, such as staples,barbs, absorbable or nonabsorbable sutures, or the like, into the skinsurface 204 to close the incision. As another alternative, a closuretool 532 using any suitable nonpenetrating fastener, such as liquidadhesive, adhesive strips, magnets, suction devices, or the like, couldbe used. The tool carriage 522′ is placed into engagement with theguiding rails 210 through any suitable means, such as the depictedfollowing channels 528. Any suitable motive force is applied to the toolcarriage 522, directly or indirectly, to cause the stapler 640 to movein the transverse direction 530 along the action path 526. The stapler640 or other closure tool 532 is actuated during this motion,continuously or at discrete intervals, to fasten the incision closed.Optionally, detents, a ratcheting structure, visible markings along theguiding rails 210, or any other aid may be provided to assist the userwith automatically and/or manually actuating the stapler 640 atpredetermined intervals during travel of the stapler 640 and associatedtool carriage 422′ along the guiding rails.

Optionally, a dimension, such as the lateral width, of the tool carriage522′ may be chosen to exert a desired direction and amount of force onthe skin surface 204 during use of the apparatus 100. For example, it iswell-known in the art that it is desirable to compress incision edgestogether during incision closure, such that the edges mutually evert andthe dermal layers are brought firmly into contact and fastened/held inthe everted configuration when the incision is closed, to facilitatewound healing. Accordingly, it will often be desirable for the toolcarriage 522′ to exert a laterally oriented compressive force on theskin surface 204 through engagement between the guiding and followingstructures when the guiding substrate(s) 202 are attached to the skinsurface, similarly to the previously described tensioning of the skinsurface during use of the apparatus 100. In the arrangement of FIGS.6A-6B, the lateral width of the tool carriage 522′ has been selected topull the guiding rails 210 inward to a third spacing distance 642, whichis narrower than the (neutral) first spacing distance 320, and therebylaterally compress the skin surface 204. However, the amount ofcompression on the skin surface 204 should be chosen to permit travel ofthe stapler 640 head along the action path 526 and to ensure that theinserted fasteners find sufficient purchase in the patient tissue.

Optionally, and as shown in FIG. 7, a maintenance jig 744 may beprovided for postoperative use. The maintenance jig 744, like theplacement jig 314, includes a jig body 316 and at least one structure,such as the depicted jig channels 316 for engaging a guiding substrate202 and/or guiding rail 210. The maintenance jig 744 engages the guidingrails 210 (or other guiding structure) similarly to the way theplacement jig 314 does, so that description will not be repeated here.When present, the maintenance jig 744 is attachable (directly orindirectly) to the guiding substrate(s) 202 for maintaining asubstantially fixed relationship between two guiding substrates, or aguiding substrate and the skin surface 204, at a substantially laterallyoriented fourth spacing distance 746, which may also be considered a“maintenance” distance. It is contemplated that, when a maintenance jig744 is used, it will be configured for relatively long-term presence onthe skin surface 204 to help facilitate healing.

The fourth spacing distance 746 may be smaller than the (laterallyneutral) first spacing distance 320, in order to urge the guidingsubstrates 202 laterally closer together and thereby exert a laterallyoriented compressive force on the skin surface 204 adjacent the accesssite 212 to hold the incision edges in the everted position duringhealing. When a maintenance jig 744 is provided after the incision hasbeen made (and, optionally, closed by the closure tool 532), themaintenance jig may serve to hold the guiding rails 210 or any otherstructure(s) of the apparatus 100 in a predetermined relative distance,such any of the first through fourth spacing distances 320, 538, 642, or746, as desired.

FIG. 8 depicts an optional configuration of the apparatus 100 wherein apair of transverse stretchers 848 are provided at either end of theguiding rails 210. The stretchers 848 are fastened in any suitablemanner (e.g., adhesives, barbs, sutures, or any other manner) to theaccess site 212 at or near the spaced-apart endpoints/apices of theincision 850. The stretchers 848 each have a substantially rigid, hingedstructure with the hinge located at or near the incision. As the guidingrails 210 are brought closer together to exert a laterally compressiveforce on the skin surface 204, the hinges of the stretchers 848 movetransversely away from the incision 850 to cause an “accordion” motionwhich exerts tension on the incision endpoints and thereby tensions theincision 850 and/or skin surface 204 in the transverse direction 530.

FIGS. 9-10 depict an example use sequence for an apparatus 100 accordingto an embodiment of the present invention. In FIG. 9, the guidingstructures (here, guiding rails 210) have been placed in the desiredlocations with respect to the access site 212. The guiding substrates202 have been directly fastened to the skin surface 204 to maintain therelative spacing between the guiding rails 210 and the access site 212.A first tool carriage 522, carrying a scalpel 534, has been placed intoengagement with the guiding rails 210 and motive power supplied by theuser's hands is causing motion of the first tool carriage 522 along theaction path 526 to bring the scalpel into penetrating contact with theskin surface 204 and thereby make the incision 850. Optionally, thefirst tool carriage 522 lateral width has been chosen to laterallytension the skin surface 204 at the access site 212 (in the left-rightdirection, in this Figure). When the incision 850 has been made, thefirst tool carriage 522 is removed from the vicinity of the incision,and the guiding rails 210 remain. The surgical procedure requiringaccess through the incision 850 can then be performed.

In FIG. 10, the surgical procedure is complete and a second toolcarriage 522′ has been placed into engagement with the guiding rails210. The second tool carriage 522′ has a smaller lateral width than thefirst tool carriage 522, such that compressive force is laterallyexerted—in the left-right direction, in this Figure—upon the skinsurface 204 at the access site 212. As can be seen in FIG. 10, thecompressive force has caused the skin surface 204 to elevate as theincision 850 edges at least partially evert under the influence of thecompressive force. A plurality of staples 1052 have been placed, usingthe stapler 640 carried along the action path 526 by the second toolcarriage 522′, across the incision 850 and into penetrating contact withthe skin surface 204 to close the wound. Downward pressure(perpendicular to the lateral plane) by the user on at least a portionof the apparatus 100 during incision 850 closure may also help to evertthe incision edges in a desired manner.

In some cases, the incision 850 edges might fail to evert as desiredunder the compressive force or may even at least partially invert. Inthese cases, the user can manually evert at least a portion of theincision 850 edges, or the apparatus 100 may include any desiredstructure to help provide the described eversion. For example, FIG. 11schematically shows a side view of the apparatus 100 in which a closingkeel 1154 is carried by a tool carriage 522 along the length of theincision 850. The closing keel 1154 is shaped for interposition betweenthe incision 850 edges to urge those edges upward into an evertedposition, as shown. The closing keel 1154 may be used sequentially orsimultaneously with a stapler 640 or other portion of the apparatus 100.

Once the staples 1052 have been placed as desired, the second toolcarriage 522′ is removed from the vicinity of the closed incision 850. Amaintenance jig 744 may then be placed across the access site 212(optionally maintaining compression on the access site), and may remainin place as long as desired by the user. When present, the maintenancejig 744 may help to protect the fragile incision 850 area of the skinsurface 204 from unwanted and potentially damaging contact with germs,other structures, or the like, and may also keep tension away from theincision 850 and decrease tissue motion at/near the access site 212. Themaintenance jig 744 may also or instead help provide or maintain asupply of a medicament at the access site 212, to assist with woundhealing. The maintenance jig 744 may also or instead have an absorbentfeature to help capture fluids draining from the incision 850 duringhealing. When the guiding rails 210 are no longer needed—at the end ofsurgery or after a maintenance jig 744 is removed, for example—theguiding substrate(s) 202 can be removed from the skin surface 204 in anydesired manner.

It is contemplated that a laparoscope port (not shown) could be providedto a tool carriage 522 such that the apparatus 100 holds the laparoscopeport in a desired position with respect to an access site 212, such asby extending into the patient's body through the incision 850 in theskin tissue. Optionally, the incision 850 could be significantly largerin the lateral plane than is the laparoscope port; in this event, theincision may be at least partially closed around the laparoscope port,through use of the apparatus 100 or conventionally. The laparoscope portis then removed and the incision 850 closure completed at the end of thesurgical procedure for which the laparoscopic access is desired. Throughuse of a laparoscope port, the user can avoid placing unwanted stress onthe edges of the incision 850 during a surgical procedure.

It is also contemplated that, while the placement and maintenance jigs314 and 744 are shown herein as relatively large, planar constructs,these components may instead be relatively narrow flexible or rigidstrips, or have any other configuration relative to the guidingstructures to perform the tasks described herein. For example, theguiding rails 210, or other type of guiding structure, could bemanufactured integrally with a placement jig 314, which is thenfrangibly removed from the guiding rails once the guiding substrates 202have been installed on the skin surface 204 as desired.

It is additionally contemplated that the closure tool 532 could beomitted from a particular use application of the present invention,particularly when a maintenance jig 744 is provided to hold the incision850 edges together for healing without any additional incision-closureaids.

Further, it is contemplated here that a tool carriage 522 could act as aplacement jig 314 and/or a maintenance jig 744, particularly when thetool carriage is not carrying a tool. The width of such a multi-purposetool carriage could be adjustable (e.g., through the use of aspring-biased width-wise telescoping structure), to assist withproviding the various spacing distances described herein.

It is also contemplated that the guiding rails 210 or other guidingstructure may interact with other portions of the apparatus 100 (e.g.,the tool carriage(s) 522) in a manner other than the sliding engagementshown. For example, any suitable structures of the apparatus 100 couldbe designed to include one or more wheels/rollers/spindles for rollingengagement, a “tank tread” type track for semi-rolling engagement, orany suitable guiding engagements or combinations thereof.

A “triggering” mechanism could be included to indicate when the toolcarriage 522 has reached a predetermined location along the action path526. The triggering mechanism could also or instead cause some type ofaction to occur (e.g., placement of staple, actuation of laser, or anyother desired action) when the tool carriage 522 has reached apredetermined location along the action path 526. The triggeringmechanism could be of any desired type such as, but not limited to, acog on the tool carriage 522 engaging holes on the guiding substrate202, a distance-measuring wheel on the tool carriage, a proximity sensoron any portion of the apparatus 100, or any other suitable type orcombination of types.

Through use of the apparatus 100 described herein, a precisely placedincision 850 can be made. The precision of the incision 850 location,combined with the fixed and known distance(s) between the guidingstructure(s) and the incision, is important to the functioning of theguided closure tool 532. Guidance of the closure tool 532 helps provideneat, efficient, and quick closure of the incision 850, all of whichhelp with patient healing and achieving desirable surgical outcomes.

While aspects of the present invention have been particularly shown anddescribed with reference to the preferred embodiment above, it will beunderstood by those of ordinary skill in the art that various additionalembodiments may be contemplated without departing from the spirit andscope of the present invention. For example, the specific methodsdescribed above for using the apparatus 100 are merely illustrative; oneof ordinary skill in the art could readily determine any number oftools, sequences of steps, or other means/options for placing theabove-described apparatus, or components thereof, into positionssubstantively similar to those shown and described herein. Radiopaquemarkers could be placed in association with any of the describedstructures and components as desired. Any of the described structuresand components could be integrally formed as a single unitary ormonolithic piece or made up of separate sub-components, with either ofthese formations involving any suitable stock or bespoke componentsand/or any suitable material or combinations of materials; however, thechosen material(s) should be biocompatible for many applications of thepresent invention. The mating relationships formed between the describedstructures need not keep the entirety of each of the “mating” surfacesin direct contact with each other but could include spacers or holdawaysfor partial direct contact, a liner or other intermediate member forindirect contact, or could even be approximated with intervening spaceremaining therebetween and no contact. Though certain componentsdescribed herein are shown as having specific geometric shapes, allstructures of the present invention may have any suitable shapes, sizes,configurations, relative relationships, cross-sectional areas, or anyother physical characteristics as desirable for a particular applicationof the present invention. The apparatus 100 may include a plurality ofstructures cooperatively forming any components thereof and temporarilyor permanently attached together in such a manner as to permit relativemotion (e.g., pivoting, sliding, or any other motion) therebetween asdesired. While discrete fasteners are discussed herein, it iscontemplated that fasteners connected to one another in any desiredmanner may also or instead be used with the present invention. Theinteraction between the guiding structure(s) and following structure(s)is described herein as being a slidable interaction, but any suitablemeans of interaction between the two types of structures (e.g., wheel onrail or any other desired type) may be provided for a particular useenvironment of the present invention, regardless of whether the means ofinteraction results in relative motion between the guiding and followingstructures during the guiding process. Any structures or featuresdescribed with reference to one embodiment or configuration of thepresent invention could be provided, singly or in combination with otherstructures or features, to any other embodiment or configuration, as itwould be impractical to describe each of the embodiments andconfigurations discussed herein as having all of the options discussedwith respect to all of the other embodiments and configurations. Adevice or method incorporating any of these features should beunderstood to fall under the scope of the present invention asdetermined based upon the claims below and any equivalents thereof.

Other aspects, objects, and advantages of the present invention can beobtained from a study of the drawings, the disclosure, and the appendedclaims.

Having described the invention, I claim:
 1. A system for facilitatingaccess through a patient skin surface, the skin surface beingsubstantially planar and laterally oriented, the system comprising: aguiding substrate extending substantially parallel to the skin surfaceand selectively directly fastened thereto, the guiding substrate, whenfastened to the skin surface, supporting a guiding structure in asubstantially fixed relationship to an access site of the skin surface;and a tool carriage configured to accept at least a chosen one of aplurality of surgical tools for sequential interaction with the accesssite, the tool carriage including a following structure configured forselective engagement with the guiding structure such that the toolcarriage is guided along a predetermined action path when the followingstructure and guiding structure are engaged and motive force is providedto the tool carriage; wherein when the surgical tool is an incisingtool, the tool carriage is guided along the action path with theincising tool in penetrating contact with the access site of the skinsurface to create a laterally elongate incision at the access site,using the incising tool, and thereby provide access below the skinsurface; and when the surgical tool is a closure tool, the tool carriageis guided along the action path to substantially close the incision atthe access site, using the closure tool, and thereby prevent accessthrough the incision below the skin surface.
 2. The system of claim 1,wherein the guiding substrate is a first guiding substrate, the guidingstructure is a first guiding structure, and including a second guidingsubstrate extending substantially parallel to the skin surface andselectively directly fastened thereto, the second guiding substrate,when fastened to the skin surface, supporting a second guiding structurein substantially fixed relationship to an access site of the skinsurface.
 3. The system of claim 2, including a placement jig attachableto the first and second guiding substrates for maintaining asubstantially fixed relationship between the first and second guidingsubstrates at a first spacing distance.
 4. The system of claim 3,including a maintenance jig attachable to the first and second guidingsubstrates for maintaining a substantially fixed relationship betweenthe first and second guiding substrates at a maintenance spacingdistance, the maintenance spacing distance being smaller than the firstspacing distance, the placement jig being used before the surgicalincision has been made at the access site and the maintenance jig beingused after the surgical incision has been made at the access site. 5.The system of claim 4, wherein the maintenance spacing distance isselected to urge the first and second guiding substrates into exerting alaterally compressive force on the skin surface adjacent the access sitewhen the first and second guiding substrates are fastened to the skinsurface and the maintenance jig is attached to the first and secondguiding substrates.
 6. The system of claim 2, wherein, when the firstand second guiding substrates are adhered to the skin surface, the firstguiding structure is located laterally to a first side of the accesssite and the second guiding structure is located laterally to a secondside of the access site, the first and second sides of the access sidebeing laterally spaced from one another.
 7. The system of claim 1,wherein the tool is a stock surgical tool.
 8. The system of claim 2,wherein a lateral width of the tool carriage is chosen to exert at leastone of a tensile force and a compressive force on the skin surfacethrough engagement between the guiding structure and the followingstructure when the first and second guiding substrates are fastened tothe skin surface.
 9. The system of claim 8, wherein a first toolcarriage exerts tensile force on the skin surface when an incising toolis being guided along the action path and a second tool carriage exertscompressive force on the skin surface when a closure tool is beingguided along the action path.
 10. The system of claim 2, wherein, whenthe surgical tool is a closure tool, the tool carriage is configured toexert compressive force on the skin surface through engagement betweenthe guiding structure and the following structure when the first andsecond guiding substrates are fastened to the skin surface, thecompressive force acting to evert the edges of the incision such thatthe incision is closed by the closure tool with the edges held in theeverted position.
 11. The system of claim 2, wherein the first andsecond guiding substrates are located laterally equidistant from theaccess site when the first and second guiding substrates are fastened tothe skin surface.
 12. The system of claim 1, wherein the closure toolinserts a plurality of laterally spaced penetrating fasteners into theskin surface to close the incision.
 13. The system of claim 1, whereinthe action path is substantially linear and transversely oriented alongthe skin surface.
 14. A method of facilitating access through a patientskin surface, the skin surface being substantially planar and laterallyoriented, the method comprising the steps of: directly fastening aguiding substrate to the skin surface, the guiding substrate extendingsubstantially parallel to the skin surface; supporting a guidingstructure in a substantially fixed relationship to an access site of theskin surface with the guiding substrate; providing a tool carriageconfigured to accept at least a chosen one of a plurality of surgicaltools for sequential interaction with the access site, the tool carriageincluding a following structure; selectively engaging the followingstructure with the guiding structure; guiding the tool carriage along apredetermined action path when the following structure and guidingstructure are engaged and motive force is provided to the tool carriage;when the surgical tool is an incising tool, guiding the tool carriagealong the action path with the incising tool in penetrating contact withthe access site of the skin surface to create a laterally elongateincision at the access site, using the incising tool, and therebyprovide access below the skin surface; and when the surgical tool is aclosure tool, guiding the tool carriage along the action path tosubstantially close the incision at the access site, using the closuretool, and thereby prevent access through the incision below the skinsurface.
 15. The method of claim 14, wherein the guiding substrate is afirst guiding substrate and the guiding structure is a first guidingstructure, and including the steps of: directly fastening a secondguiding substrate to the skin surface, the second guiding substrateextending substantially parallel to the skin surface; and supporting asecond guiding structure in a substantially fixed relationship to anaccess site of the skin surface with the second guiding substrate. 16.The method of claim 15, including the step of attaching a placement jigto the first and second guiding substrates for maintaining asubstantially fixed relationship between the first and second guidingsubstrates at a first spacing distance.
 17. The method of claim 16,including the steps of: attaching a maintenance jig to the first andsecond guiding substrates for maintaining a substantially fixedrelationship between the first and second guiding substrates at amaintenance spacing distance, the maintenance spacing distance beingsmaller than the first spacing distance; using the placement jig beforethe surgical incision has been made at the access site; and using themaintenance jig after the surgical incision has been made at the accesssite.
 18. The method of claim 17, including the step of, when the firstand second guiding substrates are fastened to the skin surface and themaintenance jig is attached to the first and second guiding substrates,urging the first and second guiding substrates with the maintenance jiginto exerting a laterally compressive force on the skin surface adjacentthe access site.
 19. The method of claim 15, including the step of, whenthe first and second guiding substrates are fastened to the skinsurface, choosing a lateral width of the tool carriage to exert at leastone of a tensile force and a compressive force on the skin surfacethrough engagement between the guiding structure and the followingstructure.
 20. The method of 19, including the steps of: exertingtensile force on the skin surface with a first tool carriage when anincising tool is being guided along the action path; and exertingcompressive force on the skin surface with a second tool carriage when aclosure tool is being guided along the action path.
 21. The method ofclaim 15, wherein the surgical tool is a closure tool, and including thesteps of: exerting compressive force on the skin surface with the toolcarriage through engagement between the guiding structure and thefollowing structure when the first and second guiding substrates arefastened to the skin surface; and everting the edges of the incisionwith the compressive force such that the incision is closed by theclosure tool with the edges held in the everted position.
 22. The methodof claim 14, including the step of using the closure tool to insert aplurality of laterally spaced penetrating fasteners into the skinsurface to close the incision.
 23. A device for facilitating accessthrough a patient skin surface, the skin surface being substantiallyplanar and laterally oriented, the device comprising: a pair of guidingrails fastened to the skin surface, the guiding rails being laterallyspaced along the skin surface with an access site on the skin surfaceinterposed laterally between the guiding rails; at least one toolcarriage configured to movably engage the guiding rails such that motiveforce exerted in the transverse direction upon the tool carriage causesthe tool carriage to move, guided by the rails, in the transversedirection; an incision tool selectively carried by a tool carriage andaccordingly guided by the movable engagement between the tool carriageand the guiding rails to create a transversely extending incision in theskin surface at the access site and thereby provide access through theskin surface; and a closure tool selectively carried by a tool carriageand accordingly guided by the movable engagement between the toolcarriage and the guiding rails to close the incision in the skin surfaceat the access site and thereby substantially prevent access through theskin surface.
 24. The device of claim 23, wherein the guiding rails areeach substantially linear and are transversely oriented along the skinsurface.
 25. The device of claim 23, including a placement jigselectively engageable with the guiding rails, the placement jig beingconfigured to place the guiding rails at a predetermined lateral neutralrail space distance relative to one another before the guiding rails arefastened to the skin surface, and the placement jig maintains thatneutral rail space distance between the guiding rails during fasteningof the guiding rails to the skin surface.
 26. The device of claim 23,wherein the tool carriage that carries the incision tool is a first toolcarriage and the tool carriage that carries the closure tool is a secondtool carriage.
 27. The device of claim 26, wherein the first toolcarriage is dimensioned to urge the guiding rails to a predeterminedlateral tensing rail space distance and thereby exert tensile force onthe skin surface during creation of the incision.
 28. The device ofclaim 26, wherein the second tool carriage is dimensioned to urge theguiding rails to a predetermined lateral compressing rail space distanceand thereby exert compression force on the skin surface during closureof the incision.
 29. The device of claim 28, wherein the compressionforce at least partially everts the edges of the incision together andthe closure tool closes the incision with the edges held in the evertedposition.
 30. The device of claim 23, wherein the closure tool inserts aplurality of laterally spaced penetrating fasteners into the skinsurface to close the incision.
 31. The device of claim 23, including amaintenance jig selectively engageable with the guiding rails, themaintenance jig being configured to place the guiding rails at aselected one of a predetermined lateral neutral rail space distance anda predetermined lateral compressing rail space distance relative to oneanother after the incision has been closed, and the maintenance jigmaintaining that selected rail space distance between the guiding railsafter conclusion of the surgical procedure for which access through theskin surface was provided by the incision at the access site.